This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
7
GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension
Covance Early Clinical Services
Madison, Wisconsin, United States
Area under the whole blood and plasma concentration versus time curve (AUC)
Time frame: 0 to 648 hours post dose
Peak whole blood and plasma concentration (Cmax)
Time frame: 0 to 168 hours post dose
Time to peak whole blood and plasma concentration (Tmax)
Time frame: 0 to 168 hours post dose
Half-life (T 1/2)
Time frame: 0 to 168 hours post dose
Percent total recovery of radioactivity in blood, urine, and feces
Time frame: 0 to 648 hours post dose
Identification of metabolites in whole blood, plasma, urine, and feces following [C14] GBT440 administration
Time frame: 0 to 168 hours post dose
Number of participants with adverse events
Time frame: Baseline to 27 days
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